Almost all menopausal and post-menopausal women, many women over thirty-five, and most women over forty years of age, and some older men frequently complain that the natural oiliness of their skin is markedly diminished.
A paper entitled "The Effect of Aging on the Activity of the Sebaceous Gland in Man" by Pochi. P. E. and Strauss, J. S. that was published in Advances in Biology of Skin, Vol VI: Aging, edited by Montagna, W., Pergamon Press, N.Y. (1965), described the reduction in mean sebum (oil) secretion in males and females in relation to advancing age. FIG. 1 herein illustrates this reduction in mean sebum production with aging.
Testosterone therapy increases skin oil production in menopausal and post-menopausal women. However, it produces unwanted superfluous facial and body hair and other systemic masculinizing side effects and is therefore rarely used.
Dehydroepiandrosterone is a steroid. It and its sulfate are secreted by the adrenal glands, circulate in the bloodstream, and are excreted in urine as derivatives of dehydroepiandrosterone.
As shown in FIG. 2, dehydroepiandrosterone sulfate levels in the blood have been shown to reach a peak in early adult life and then gradually decline with advancing age (Orentreich Foundation for the Advancement of Science, Inc., Annual Report, 1979).
The structure for dehydropiandrosterone is as follows: ##STR1##
In a study entitled "Biological Activity of Dehydroepiandrosterone Sulfate in Man" by Drucker, W. D., Blumberg, A. M., Gandy, H. M., David, R. R., and Verde, A. L., that was published in the Journal of Clinical Endocrinology and Metabolism, 35: 48-54 (1972), sebum production was used as a measure of androgenic activity associated with the oral administration of dehydroepiandrosterone sulfate. Drucker et al., however, did not address the problem of dry skin in normal older women and some older men. Indeed, the experiments of Drucker et al. were conducted with five abnormal, androgen-deficient, hypogonadal males, ages 15, 20, 30, 34 and 35, and a three-month-old female with 21-trisomy syndrome.
In U.S. Pat. No. 4,005,200, a new use of dehydroepiandrosterone sulfate as a parturient canal conditioning agent was disclosed. U.S. Pat. No. 4,005,200 describes systemic administration of dehydroepiandrosterone sulfate to a pregnant female during the 37th to 39th week of pregnancy to improve the maturity of the parturient canal and the sensibility of the uterine musculature to oxytocin. U.S. Pat. No. 4,005,200 mentions that it had been proposed to use dehydropiandrosterone sulfate clinically in combination with estrogens in the treatment of various syndromes associated with climacterium, but the problem of skin dryness was not addressed in this patent.
In recent articles (Jan. 17, 1982 edition of Science News, "Antiobesity Drug May Counter Cancer, Aging"; Jan. 22, 1981 edition of the Chicago Tribune, "Amazing New Drug That May Lead to Longer Life", Kotulak, R.), uses of dehydroepiandrosterone and analogs thereof were described to counter obesity and prevent cancer. These articles did not, however, address the problem of skin dryness.
I previously discovered a method (described in my prior copending application Ser. No. 345,835 now abandoned) for treating dry skin in humans by internally administering an effective dosage of the alcohol and/or one or more salts of dehydroepiandrosterone. This treatment is particularly useful in treating dry skin in menopausal women. This treatment can also be employed to treat premenopausal females with a low endogenous dehydroepiandrosterone production. Furthermore, males who suffer from dry skin due to low plasma levels of testosterone and/or dehydroepiandrosterone and its sulfate can be treated in accordance with my previous invention.
Menopausal and post-menopausal and other older women usually have a distinct reduction in dehydroepiandrosterone sulfate levels in the blood which is generally accompanied by a reduction in the oil production of the skin and results in dryness of the skin. Such dry skin problems generally affect the entire body. The face and head, however, have the highest population of sebaceous glands and therefore those areas are the mose vulnerable to these problems. I previously found that the internal administration of the alcohol or one or more salts of dehydroepiandrosterone increases the blood level of dehydroepiandrosterone and its sulfate and reduces skin dryness. The reduction of activity of sebaceous glands with aging and at the onset of menopause is reversed by the internal administration of dehydroepiandrosterone alcohol or dehydroepiandrosterone sulfate.
Xeroderma, i.e., dry skin, can be caused by a multiplicity of factors and can be aided by the use of exogenous and water retentive products. I previously found that internal administration of dehydroepiandrosterone alcohol or dehydroepiandrosterone sulfate increases the endogenous production and secretion of natural sebum and enhances the water protective barrier of the skin, thus acting as a natural moisturizer.
Oral ingestion or other systemic administration of dehydroepiandrosterone or its derivatives results in an increase in oil production by all sebaceous glands over the entire body, an effect that is frequently undesirable or unnecessary. The present invention permits obtaining the above-described desirable effects on a localized basis, only at the places where such effects are desired or necessary.